drugset / Trial / NCT03549299
Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD
Phase 1/2
Unknown
16 enrolled
RHEACELL GmbH & Co. KG
FGK Clinical Research GmbH · collabGranzer Regulatory Consulting & Services · collabTiceba GmbH · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The aim of this clinical trial is to investigate the efficacy (by monitoring neovascularization and epithelial defects) of up to four doses of the investigational medicinal product (IMP) LSC2 topically administered on the target eye of patients with LSCD. Further, safety of the IMP during and after application will be investigated (by monitoring adverse events \[AEs\]).
Timeline
- Start
- 2019-07-04
- Primary completion
- 2023-09
- Completion
- 2023-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LSC2 | Cell therapy | 75000 cells | Topical |
| Subject | LSC2 | Cell therapy | 300000 cells | Topical |
| Subject | LSC2 | Cell therapy | 800000 cells | Topical |
| Subject | LSC2 | Cell therapy | 1.2e+06 cells | Topical |